OncoMatch/Clinical Trials/NCT06583993
A Clinical Trial Evaluating the Safety and Efficacy of Intravenous HNF4α srRNA in Treating Advanced ICC Patients
Is NCT06583993 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies HNF4α srRNA for intrahepatic cholangiocarcinoma.
Treatment: HNF4α srRNA — The goal of this investigator-initiated, a single-arm, open-label, pilot study is to investigate the safety, tolerability, and efficacy of intravenous HNF4α srRNA treatment in subjects with advanced Intrahepatic Cholangiocarcinoma (ICC). Condition of disease: advanced intrahepatic cholangiocarcinoma Intervention： HNF4α srRNA will be administered intravenously for the treatment of ICC. The dosing regimen is planned for a second dose 14 ± 3 days post-initial treatment, followed by subsequent treatments every 28 ± 7 days, with adjustments made based on patient tolerance and therapeutic response. This is a dose escalation assay employing a i3+3 design to assess escalating HNF4α srRNA dosages: 25 μg, 50 μg, and 100 μg. Post-initial dose, a 14-day dose-limiting toxicities (DLT) observation will evaluate tolerability and safety, guiding dose adjustments or selection of the Recommended Dose (RD) for the expansion phase. Cohorts may include up to 9 participants, adjusted for safety. Drug: HNF4α srRNA, a drug specifically designed to target liver cancer cells and facilitate the expression of HNF4α. According to Amendment 1, patients who have received at least 4 cycles of HNF4α srRNA therapy and have a tumor assessment of SD (stable disease) or PD (progressive disease) per RECIST v1.1 criteria may, after a comprehensive evaluation by the investigator considering the patient's treatment history and the current safety and efficacy data of HNF4α srRNA, continue HNF4α srRNA at the same dose, or have their dose adjusted, in combination with immunotherapy, targeted therapy, or chemotherapy.
Check if I qualifyExtracted eligibility criteria
Cancer type
Cholangiocarcinoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: chemotherapy (gemcitabine, fluoropyrimidine, platinum)
progressed after at least one chemotherapy regimen containing gemcitabine/fluoropyrimidine/platinum, etc.
Cannot have received: local or systemic anti-tumor treatments (ablation, Transhepatic Arterial Chemotherapy and Embolization (TACE), local radiotherapy of the liver, immunotherapy, targeted therapy)
Exception: except for treatment regimens assessed as disease progression according to RECIST v1.1
Patients who have received local or systemic anti-tumor treatments such as ablation, Transhepatic Arterial Chemotherapy and Embolization (TACE), local radiotherapy of the liver, immunotherapy, targeted therapy, etc., within 4 weeks
Cannot have received: chemotherapy, other trial drugs, or radiotherapy of metastatic lesions
Exception: except for treatment regimens assessed as disease progression according to RECIST v1.1
chemotherapy, other trial drugs, or radiotherapy of metastatic lesions within 2 weeks
Lab requirements
Blood counts
ANC >= 1.0×10^9/L, Platelets >= 30×10^9/L, Hemoglobin >= 8.5 g/dL, INR <= 2.3
Kidney function
creatinine <= 1.5 × ULN or calculated creatinine clearance >= 40 mL/min
Liver function
Albumin (ALB) >= 25 g/L, total bilirubin <= 5 × ULN, AST/ALP/ALT <= 10 × ULN
Albumin (ALB) < 25 g/L, or total bilirubin > 5 × ULN, or AST, ALP, or ALT >10 × ULN. Creatinine >1.5 × ULN or calculated creatinine clearance < 40 mL/min. ANC < 1.0×10^9/L, or Platelets < 30×10^9/L, or Hemoglobin < 8.5 g/dL. INR > 2.3.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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